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Procedure
De-Epithelialization Techniques for Gum Recession
N/A
Waitlist Available
Led By Sandra Stuhr, DMD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 7, 14, 21 (post-operative) after surgery
Awards & highlights
Study Summary
This trial will compare different techniques for skin removal during plastic surgery to see which is best for healing & outcomes.
Who is the study for?
This trial is for individuals with good physical and mental health who need dental surgery involving soft tissue grafts. They must be able to follow study instructions but can't join if they have infections, recent heavy antibiotic use, uncontrolled diabetes, are pregnant or nursing, have severe blood disorders, cancer treatments within the last 18 months, smoke heavily, or have liver/kidney diseases.Check my eligibility
What is being tested?
The trial compares four techniques of gum preparation in dental surgery: using a surgical blade, mucotome device, diamond bur tool or an Er:YAG laser. It looks at how much gum remains after treatment and how well the wound heals.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of surgery, delayed healing of the gums or donor sites following de-epithelialization procedures. Specific side effects could vary based on the technique used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 7, 14, 21 (post-operative) after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 7, 14, 21 (post-operative) after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Histomorphometric Comparison
Secondary outcome measures
Patient-reported outcome measures
Surgical Time
Wound healing
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: MucotomeExperimental Treatment1 Intervention
A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Group II: Er:YAG LaserExperimental Treatment1 Intervention
A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Group III: Diamond BurExperimental Treatment1 Intervention
A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Group IV: Surgical BladePlacebo Group1 Intervention
A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Er:YAG Laser
2018
N/A
~70
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,888 Total Patients Enrolled
5 Trials studying Gingival Recession
158 Patients Enrolled for Gingival Recession
Delta Dental FoundationOTHER
7 Previous Clinical Trials
1,387 Total Patients Enrolled
1 Trials studying Gingival Recession
20 Patients Enrolled for Gingival Recession
Sandra Stuhr, DMD, MSPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune or inflammatory condition like lupus or rheumatoid arthritis.I am in good or mild systemic disease state according to ASA.I have a severe blood disorder like leukemia or hemophilia.I have not taken antibiotics or immunosuppressants in the last 3 months.I am currently taking medication to prevent blood clots.I am having a gum surgery that includes taking tissue samples without needing extra anesthesia.I am physically and mentally fit for routine dental care.I do not have any infections that could affect my healing.I am taking other medications that could influence the study's results.I have liver or kidney disease.I am currently undergoing cancer treatment or finished it within the last 18 months.My diabetes is not well-managed, with an HbA1c of 7.0 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Blade
- Group 2: Mucotome
- Group 3: Diamond Bur
- Group 4: Er:YAG Laser
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any avaialble spots for participants in this experiment?
"The clinicaltrials.gov portal reveals that, as of July 12th 2023, this trial is not actively recruiting participants; though 107 other trials are seeking enrolment. This study was posted to the website on August 1st 2023 and has since been updated multiple times."
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